Thursday, April 30, 2020

News Coverage of Capricor and California Stem Cell Agency Less Than Abundant


Capricor Therapeutics' stock price retreated today after soaring 253 percent yesterday on the news that one of its products had successfully treated a small group of critically ill, Covid-19  patients.

The price closed today at 7.00, down from yesterday's close of $8.50. That was the highest price for the Beverly Hills firm since 2018.

While the news about its CAP-1002 treatment excited investors, it did not stir the news media. In the glut of hundreds of stories about the coronavirus, the mainstream media did not even mention Capricor. Nor did the Los Angeles Times, virtually the home town paper for the firm. As for the California stem cell agency, which has pumped nearly $25 million into Capricor-related research, the role of the agency was also among the missing.

The Los Angeles Business Journal did carry a tidy and straight forward story, again one that did not mention the stem cell agency, which is hoping that California voters will save its financial life next fall. That is, if they approve a proposed, $5.5 billion, ballot measure that has already missed one state-recommended deadline (April 21) for qualifying for the ballot. BioWorld also had a story that did not mention the California agency's role. 

The agency is running out of the $3 billion that voters provided for it in 2004 when they created the unprecedented state research program. It will begin closing its door in six months unless major funding is found.

The sparse news coverage of the agency will be a challenge for the agency's backers as they seek voter approval of the ballot measure, assuming it qualifies.

Wednesday, April 29, 2020

A Covid-19 Success, 300 Percent Stock Price Increase and the California Stem Cell Agency

A company that the California stem cell agency has backed with nearly $18 million scored big this morning on news that one of its products had generated a 100 percent survival rate with a small group of critically ill Covid-19 patients.

The company is Capricor, Inc., a publicly traded company based in Beverly Hills, Ca. Its stock soared more than 320 percent at one point this morning from its previous close of $2.41 based on the news about its CAP-1002 therapy. Shares stood at $9.09 at the time of this writing.  

The company said in a news release that it had generated "100 percent survival in critical Covid-19 patients who were treated with Capricor’s lead asset, off-the-shelf ('allogeneic') cardiac cell therapy CAP-1002, at Cedars-Sinai Medical Center as part of six compassionate care cases." 

The company said the federal government has approved 20 additional patients for treatment. Capricor also said it is developing "a randomized, placebo-controlled trial planned to treat patients with moderate and severe disease which is intended to be funded by non-equity capital."

Capricor and its underlying research have long been embedded with the state stem cell agency, which is formally known as the California Institute for Regenerative Medicine (CIRM). In addition to $17.8 million given directly to the company, another $7 million went to Cedars-Sinai for much of the early development work that led to the creation of Capricor. 

Speaking to the agency's governing board in 2016 concerning CAP-1002, CIRM director Jeff Sheehy, chair of its Science Committee, said, 
"This is pretty much a pure CIRM product. They came into our first disease team to develop the product. We've supported two of the three clinical trials. So if this turns out to be a major success, this will be a real feather for CIRM. We've been with them all the way. So I'm optimistic." 
In 2018, a clinical trial involving CAP-1002 was begun at UC Davis as part of CIRM's separate Alpha Clinics program, an ambitious statewide effort to lead the way nationally on stem cell research.

In a news release this morning, Linda Marban, CEO of Capricor, said, 
"As the global medical community continues to come together in its battle against COVID-19, the results of our initial compassionate care cases are extremely promising and what we had anticipated. We look forward to continuing to treat additional patients under our recently approved expanded access program Investigational New Drug application.
“CAP-1002 is an easy-to-deliver intravenous therapy that has been administered successfully to over 150 patients to date. Given its novel mechanism of action, it could be a potential game-changer in helping countless Covid-19 patients.”
The Capricor product initially targeted Duchenne muscular dystrophy (DMD), "a muscle wasting condition that steadily destroys the muscles in the arms and legs, heart and respiratory system" of boys and "never lets up," CIRM says.

The CAP-1002 treatment has demonstrated immunomodulatory properties that come into play with Covid-19. Capricor said, 
"Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of Covid-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing pneumonia, organ failure and death. Therefore, it can be the body's overreaction to Covid-19, rather than the virus itself, that delivers the fatal blow."

Friday, April 24, 2020

The Covid-19 Fight: $1 Million Awarded by California Stem Cell Agency for Research

The California stem cell agency this morning awarded $1 million to three researchers for work aimed at battling the coronavirus, which has taken more than 1,500 lives in California and nearly 45,000 nationally.

The grants are the first coronavirus research to be funded by the agency, formally known as the California Institute for Regenerative Medicine (CIRM). Maria Millan, CEO and president of CIRM, said in a news release,
“We are in the midst of very challenging times where there is not yet an approved treatment for COVID-19. In response to this, CIRM launched and executed an emergency COVID-19 funding program, which was made possible by our board, patient advocates, California scientists, external scientific expert reviewers and our dedicated team."
Millan cited one application in particular.  She said,
“With CIRM funding, the City of Hope COVID-19 Coordination program will tap into CIRM’s network of researchers, physicians, and our Alpha Clinics to deliver this treatment to patients in need.  It will also serve the critical role of gathering important scientific data about the plasma, safety, and clinical data from treated patients.”
The City of Hope application received the most funding in today's round, $749,999. It went to a team led by John Zaia.

The proposed research would involve development of a program in California to identify potential blood plasma donors who could take part in a Covid-19 treatment program. A summary of the reviewers' comments on the Zaia application (Clin2dovid19-117) said,
“This will help develop a new screening tool for the California public health arsenal by identifying what patient and (plasma) donor factors predict clinical benefit.”
The other two awards went to Gay Crooks of UCLA$150,000, (Disc2covid19-11817) and Brigitte Gomperts, also of UCLA, $149,998 (Disc2covid19-11764).

Crooks is seeking to enhance the ability to generate specialized immune cells in the lab and use them to discover viral antigens that have the highest potentcy for vaccines.

Gomperts is aiming identifying a federally approved lead compound that could be repurposed for Covid-19 infection.

CIRM's out-of-state reviewers had questions or concerns about each proposal, which can be found in the summaries of reviewer comments. Zaia wrote a letter dealing with some of the reviewer comments, noting that the application was prepared on a short timeline and more work had answered some of the key questions.

CIRM directors gave higher prior to plasma applications that had strong plans for "outreach and study participation by under-served and disproportionately affected populations." Zaia's three-page letter devoted full page to an outline of that effort. Other applicants did not submit a letter to the CIRM board.

Nine applications were rejected by reviewers, whose decisions are nearly invariably rubber-stamped by the board. The board continued that longstanding tradition today. 

CIRM has speeded up its normal processes to gather applications and act on them. Winners are expected to begin work 30 days from today. "Deliverables" are expected in six months. 

The applications considered today were among 19 submitted April 7, the first deadline for the $5 million round. The seven not reviewed did not meet the eligibility criteria.  Sixteen more applications were received last Tuesday. The next deadline for applications is May 5.

Directors expect to act in the middle of next month on more applications. 

Skating Past Deadlines: $5.5 Billion Stem Cell Campaign Silent on Critically Needed Signatures

Backers of a $5.5 billion stem cell research proposal this week dodged past another critical, but self-imposed deadline for placing the measure before California voters. They eliminated it. 

It was the fourth deadline that the campaign has either missed or eliminated. The move came as the campaign itself has noted.
"Time is running out."
The ballot initiative -- if it makes the fall ballot and is approved by voters -- would save the state stem cell agency from financial extinction. Originally funded in 2004 with $3 billion in borrowed state money, the agency is expected to be down to its last $26 million by the end of the day today. Formally known as the California Institute for Regenerative Medicine (CIRM), the agency is expected to award $1.0 million this morning for Covid-19 research. 

The campaign is seeking 950,000 signatures of registered voters to qualify its initiative for the ballot. As of early this month, it said it had 915,000 but has remained mum since then on the number of signatures it has gathered. 

Legally, the measure needs 623,212 signatures of registered voters. Typically, however, a high percentage of signatures collected for initiatives are disqualified, sometimes as high as 50 percent. 

State election officials recommend that the signature petitions be submitted to election officials in 58 counties by April 21 to allow officials to perform the time-consuming work of verifying hundreds of thousands of signature. County election offices, however, are hard hit by stay-at-home, Covid-19 restrictions affecting their operations. If the verification work is not completed by June 15, the initiative will not be placed on the ballot. 

The campaign has laid out its changing deadlines on a web page exhorting supporters to engage in an unusual Internet and mail-in petition effort. Earlier this week, after the campaign missed its third deadline, wording on the page was changed to remove a specific date. As of this writing, the latest "deadline"  exhortation said, 
"The campaign must gather the last 35,000 signatures through mail-in submissions ASAP."
On Wednesday, the campaign told the California Stem Cell Report it would be submitting petitions to county officials "in the next two weeks." The campaign did not respond this morning by the time of this writing to questions about the signature-gathering effort. However, one Santa Barbara resident told us that he received a petition packet this morning in standard postal mail from the campaign asking him to sign the petition and return it to the campaign. 

(As this item was being posted, the campaign emailed a response concerning the status of its signature-gathering. However, the statement only repeated what the campaign said days earlier and did not contain any new information.)

Wednesday, April 22, 2020

California Stem Cell Agency Set to Award Millions on Friday for Coronavirus Research

The California stem cell agency is moving with dispatch to approve millions of dollars for stem-cell related research that would assist in the battle to fend off Covid-19 and ease the coronavirus crisis.

Meeting behind closed doors yesterday, the agency's reviewers  evaluated 12 applications seeking $2.7 million in total funding, including one proposal at a clinical stage. The proposals were received about two weeks ago and were the first in the agency's special Covid-19s round. 

It is standard practice for the reviewers to meet privately when considering applications. 

The reviewers' decisions, still undisclosed, are expected to be ratified by the agency's governing board on Friday. The researchers are expected to be ready to begin work 30 days later. 

Also yesterday, the agency received 16 more applications in the $5 million, rolling, coronavirus round. Four involved clinical applications. Three came from businesses and the rest from non-profits, including academic institutions. 

The board's meeting is open to the public via the Internet. Instructions are available on the agenda of the meeting, which begins at 11 a.m. PDT. 

Supporters of $5.5 Billion California Stem Cell Measure Miss Third Deadline, Including One Recommended by the State

Backers of a $5.5 billion, California stem cell research proposal this morning once again missed their self-imposed, but important deadline for qualifying the measure for the ballot this fall in hopes of saving the financial life of the state stem cell agency. 

It was the third time that the ballot initiative campaign has missed its own deadlines for gathering signatures as time is running out. The first deadline was April 11. The second deadline was April 18. The third deadline was April 21 (yesterday). The next deadline is April 23 (tomorrow).

Yesterday was also the deadline recommended by state election officials for submitting the signatures to all of California's 58 counties.  The state's recommendation is not a legal cutoff, but appears aimed at ensuring enough time exists to complete the lengthy certification process for the November ballot.

The proposed ballot initiative would refinance the state stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM). It is running out of its original $3 billion and is expected to begin closing its doors next fall. 

The campaign, which is independent of the agency, had little to say about its signature-gathering problems. The California Stem Cell Report this morning asked the campaign how many signatures it has on hand.  Sarah Melbostad, a spokeswoman for the campaign, replied:
"They are still in the process of counting them but we will let you know as soon as we have an updated number to share."
It was not clear whether the campaign actually knows how many signatures it currently has or whether, on the other hand, it has an actual number but is simply not releasing it publicly. The campaign did not respond to a question this morning on that matter. 

Several weeks ago, the campaign said it had 915,000 signatures. That was when it set its April 11 deadline to secure 35,000 more. It needs only 623,212 to qualify for the ballot, but many signatures are disqualified as elections official in each county checks to see whether the signatures represent actual registered voters. 

Melbostad said, 
"We’re continuing to get petitions in the mail every day from our patient advocacy-driven and direct-mail signature gathering efforts. The campaign is planning to submit signatures to the counties in the next two weeks to ensure that the counties and the state have sufficient time to count and verify signatures for the November ballot."
If election officials have not certified the necessary signatures by June 15, the stem cell measure will not appear on the ballot. The certification process can be prolonged and likely more so under the difficult conditions imposed by the coronavirus crisis. 

State election officials provide recommended deadlines under normal conditions for submitting petitions to qualify ballot measures. They depend on the method used for qualification: random sampling or "full check." Under the random sample method, the recommendation is to submit petitions to county election officials by yesterday (April 21). Under the full check method, March 3 was the recommended deadline. 


Monday, April 20, 2020

Two Deadlines Missed by Supporters of $5.5 Billion, California Stem Cell Measure

Backers of a $5.5 billion stem cell research proposal in California today have once again missed a self-imposed, but critical deadline as they continue to struggle with securing enough signatures to place the measure on the November ballot.

The campaign's website this morning listed what is now its third deadline for gathering the signatures of 950,000 voters. Previously, the campaign had set an April 11 deadline and then an April 18 deadlineThe latest deadline is tomorrow (April 21). The rolling extensions do not augur well for its "unprecedented" attempt to collect signatures via a combined online and mail-in effort. 

In response to questions from the California Stem Cell Report, Sarah Melbostad, a spokeswoman for the campaign, declined to elaborate on the campaign's progress or lack of it beyond a statement she released on Friday.


The questions ranged from just how many signatures the campaign currently has in hand to when they might be presented to election officials. (Here is a link to the text of all the questions.)


The campaign's ballot initiative is aimed at staving off the financial demise of California's stem cell agency, which has all but run out of the $3 billion that it was provided by voters in 2004, also through a ballot initiative.  Known formally as the California Institute for Regenerative Medicine (CIRM), the agency has no other significant funding source than state-issued bonds.

The coronavirus crisis has blocked the usual method of gathering of ballot initiative signatures at shopping malls and other public locations. The campaign said earlier it needed another 35,000 signatures to hit its goal of 950,000. The legal requirement is only 623,212 but many signatures are disqualified as invalid, sometimes as high as 50 percent.

Another obstacle involves officials in the state's 58 counties, who must certify the signatures. Most, if not all, are short-staffed because of the coronavirus and/or must provide a working environment that is likely to slow the signature count. If the count is not completed by June 15, the stem cell measure will not be on the November ballot and the agency will begin closing its doors.


Text of Questions to Campaign for $5.5 Billion Stem Cell Intiative

Here are the questions that the campaign for a $5.5 billion California stem cell research measure declined to address this morning. The questions were directed to the campaign by the California Stem Cell Report last Friday in connection with the campaign's then April 18 deadline for collecting signatures to qualify the measure for the fall ballot. 
  • How many signatures have been gathered for presentation to election officials? Is that number based on an estimate or actual count?
  • The campaign has said it has "no estimates to share." Does that mean that, in fact, it has estimates that it does not want to share? Is the campaign keeping a rolling total of signatures each day since it began its new mail-in effort?
  • When will the petitions be presented to election officials?
  • How long does the campaign think the count will take?
  • Does the campaign plan to try to gather more signatures either beginning this week or after it receives information about the disqualification rate?
  • Is there anything else I need to know?

Friday, April 17, 2020

Correction

A item earlier today dealing with the signature-gathering campaign for a $5.5 billion ballot measure incorrectly said that the campaign had said it had gathered 935,000 signatures. The correct figure is 915,000.

$5.5 Billion California Stem Cell Proposal: Campaign Mum on Its Ballot Qualification Numbers

Backers of a $5.5 billion, proposed ballot measure said this morning that they still cannot provide a fresh estimate of the number of voter signatures they have in their effort to save the California stem cell research program from financial extinction.

The campaign faces a self-imposed deadline of Saturday to gather the needed signatures in its initiative petition drive, which was stymied when the coronavirus crisis hit the Golden State.  While the deadline is self-imposed, it reflects the upcoming, tedious and time-consuming pace of signature verification by county election officials, who are additionally hampered by workplace restrictions currently in place.

If county officials have not verified 623,212 signatures of registered voters by June 15, the stem cell initiative will not be placed on the ballot. The campaign has said early this month that it has 915,000 signatures and needs to collect a total of 950,000 by tomorrow. That reflected a slippage from last Saturday on an earlier deadline. 

The excess beyond 623,212 is needed because high percentages of signatures are determined to be invalid in normal petition circulation efforts, sometimes as high as 50 percent.

Responding to questions from the California Stem Cell Report, the campaign released a statement this morning that said, 
"The campaign is receiving petitions in the mail every day, however it takes time to count and verify incoming petitions. 
"While we don’t have an estimate to share, we do know that over the last week website traffic has increased, with more than 10,000 people visiting our signature gathering page....
"The campaign is aiming to give the counties as much time as possible to verify signatures. However, the landscape is changing on a daily basis, and adapting to new challenges during these uncertain times requires nimble decision-making and flexibility."
The state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), is running out of the $3 billion it was originally provided in 2004. That was when another ballot initiative created the agency, supporting it with state bond funding. The agency has no other significant source of cash. CIRM could have asked the legislature and the governor for more financial support earlier, but such an effort would have faced a difficult political road. 

Without additional funding, the agency will begin to close its doors next fall. 

Other ballot initiatives are facing the same signature-gathering pressures in California and elsewhere in the country. The Guardian newspaper in the United Kingdom carried a piece yesterday looking at the issues throughout the United States. It quoted a backer of one initiative effort in California to permit collection of signatures for future initiatives electronically as saying, "It's a killer. We're done."

See here for the exact process of verifying signatures and certifying a measure for the ballot.

Correction: An earlier version of this item incorrectly said that the campaign had said that it had gathered 935,000 signatures. The correct figure is 915,000.

Thursday, April 16, 2020

Info Sources on Stem Cells and Covid-19

A California stem cell blog is digging into research involving cell therapies aimed at the coronavirus, and this week it posted a summary of the work that is underway from Texas to Israel.

The blog is called The Niche and is produced by UC Davis stem cell researcher Paul Knoepfler. On Monday, he posted a quick look at six efforts. He also has probed claims involving Rudy Giuliani. On Tuesday, Knoepfler recommended a comprehensive view of of Covid-19 efforts published by the Alliance for Regenerative Medicine, an industry group.

From the East Coast, STAT news has made its impressive coronavirus coverage available free online. STAT's stories are generally several cuts above, in terms of quality, most of the mainstream media. The STAT coverage explores more deeply many of the scientific issues along with how the work is financed and carried out by biomedical companies, including stem cell approaches. Here is a link to the STAT coronavirus lineup. 

Tuesday, April 14, 2020

Time Running Out for $5.5 Billion California Stem Cell Ballot Initiative

Backers of a proposed $5.5 billion, stem cell ballot initiative are pressing on with their cyberspace campaign to assure that the measure will qualify for the November ballot despite "a landscape (that) is changing on a daily basis."

But as the campaign's website notes, "Time is running out."

No fresh figures for the number of signatures have been released since early this month. The campaign has also extended to this Thursday its self-imposed deadline for collecting 950,000 signatures. The campaign originally hoped to have the signatures in hand last Saturday.  

At stake is the financial life of the California stem cell agency, which is running out of money and is expected to begin the process of closing its doors next fall unless it receives an infusion of cash. The ballot initiative needs 623,212 signatures of registered voters to make the November ballot.  At last report, it had 935,000. However, the disqualification rate of signatures on petitions can run as high as 50 percent. 

County election officials are also working under Covid-19 conditions, which can mean a reduced work force and limited hours for verifying signatures. At some point, moreover, the mechanics of printing and delivering the ballot information that must go to nearly 20 million voters come into play for state election officials. 

Responding to a query from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad released a statement yesterday that said:
"This new virtual signature gathering effort was launched just last week, and as it takes time to count the incoming signatures by mail, we do not have an updated number to share. 
"The campaign is aiming to give the counties as much time as possible to verify signatures, however the landscape is changing on a daily basis, and adapting to new challenges during these uncertain times requires nimble decision-making and flexibility. 
"Voters can continue to visit our website https://caforcures.com/help-us-qualify/ to sign the petition and learn how they can help ensure the continuation of treatments and cures that could save or improve the lives of millions."
The stem cell measure is not the only initiative that is facing problems. It could well be that the governor may take some sort of emergency action to extend deadlines for all of them. 

Earlier this month, the stem cell campaign launched an "unprecedented" electronic, mail-in effort to gather the final number of signatures that were judged to be needed. It is a daunting process to conduct online and then have the petitions returned in the mail. 

The campaign web site stresses the urgency and pressing need for more signatures. "The campaign must gather the last 35,000 signatures through mail-in submissions by April 16th," the web site says. 

Friday, April 10, 2020

Covid-19 and California Stem Cell Agency: Plasma Research to be Funded in $5 Million Round

California's stem cell research agency, in an "emergency" move this morning, joined the search for a plasma treatment for Covid-19, stressing the importance of extending access to minority communities. 

It was only the second time in the 15-year history of the agency that its governing board invoked its "vital research opportunity" clause, which gives it authority to divert funding from stem cell research to other purposes.

Maria Millan, CEO and president of the agency, said in a statement,
“The intent behind this amendment is to be responsive to this COVID-19 crisis by leveraging CIRM’s funding programs, processes and infrastructure within the scientific ecosystem that it has supported to date.
"By providing an opportunity for the medical and scientific community to gather important data while using convalescent plasma treatment protocols on an emergency basis, CIRM is joining the global effort to  expedite treatments to patients in need in the midst of this global pandemic."
This morning's action, approved unanimously, adds plasma research to a $5 million grant round aimed at the coronavirus.  The round has rolling application deadlines. The first was last Tuesday and drew 19 applications. The next deadline is expected in about two weeks.

The board unanimously added a provision to the plasma proposal aimed at ensuring that it would reach into minority and medically under served areas of the state. 

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), is speeding its award process and expects winning applicants to be ready to begin their work within 30 days of approval of an award.

The use of plasma in treating Covid-19 has attracted international attention as well as here in California.   

CIRM directors also approved additional members to its panel of grant reviewers, all of whom come from out-of-state. The agency selects reviewers from the panel depending on the nature of their expertise. 

Here is a link to the CIRM news release on the action today.

Thursday, April 09, 2020

California Stem Cell Agency Set to Finance Anti-Covid-19 Plasma Research

In a rare move, California's stem cell agency is set to expand beyond its traditional scope and finance research involving the use of blood plasma for treatment of Covid-19 patients. 

It would be only the second time that the agency, known formally as the California Institute for Regenerative Medicine (CIRM), has invoked the "vital research opportunity" clause in the 10,000-word ballot initiative that created the agency in 2004. 

Under the initiative, CIRM is restricted to using its $3 billion for stem cell research -- not the vast array of possibilities for the entire field of biomedical research. But a little-noticed provision also allowed for exceptions in the case of "vital research opportunities."  

The proposed action tomorrow would include plasma research in a new, $5 million effort approved two weeks ago to support stem cell research involving Covid-19. On Tuesday, the agency received 19 applications for funding under that fresh, ongoing effort. Another deadline for applications is expected in about two weeks. 

The expansion to include plasma will be presented to the CIRM governing board tomorrow at 11 a.m. PDT during a public, online meeting. It includes funding "proposals to study convalescent plasma or its derivatives (e.g., immunoglobulin) for the treatment of patients with COVID-19."

The plan also said,
"Clinical studies of convalescent plasma may propose use of the FDA’s single-patient emergency IND (eIND investigational new drug) pathway to satisfy the (agency's) CLIN2 eligibility requirements for a traditional IND."
CIRM's $5 million coronavirus effort might seem skimpy to those used to thinking of the agency as a $3 billion program. It was a $3 billion effort 15 years ago. Today the agency is running out of cash and is down to its last $27 million, which is largely committed to a sickle cell round. 

CIRM is hoping that a proposed, $5.5 billion ballot initiative will qualify for the November ballot, be approved by voters and give it at least another 10 years of life.  

The first occasion for invoking the "vital research" clause involved gene therapies. 

The public can listen in on tomorrow's meeting and make comments. Instructions for online access can be found on the meeting agenda. 

Here is a look at a national plasma effort already underway. Here are federal recommendations concerning such research. 

Wednesday, April 08, 2020

$5 Million Allotted: California Stem Cell Agency Receives 19 Applications for Research Targeting Covid-19

Nineteen scientists seeking to crush the coronavirus submitted applications this week for research grants from the California stem cell agency, which has set aside $5 million for the job. 

Details on the nature of the proposed work were not disclosed by the agency, known formally as the California Institute for Regenerative Medicine (CIRM). That's in keeping with its usual practice concerning applications that are yet to be reviewed or approved. 

The research must involve a stem cell or a drug or antibody targeting stem cells. The agency said that only research involving "development or testing of a treatment for Covid-19 (is) eligible."

The "emergency" coronavirus round was established by the agency just two weeks ago. CIRM plans to deliver funds quickly to the winning applicants. The researchers are expected to be ready to begin work within 30 days of approval of the awards. 

The agency allocated the $5 million on March 27. Yesterday was the first deadline for applications. The next is expected in about two weeks.  The agency has said it would fund all stages of research from basic to clinical. Maria Millan, president and CEO of the agency, said earlier in a statement
“These are clearly extraordinary times and they require an extraordinary response from all of us.... California researchers have made us aware that they are pursuing potential stem cell based approaches to the COVID-19 crisis, and we felt it was our responsibility to respond by doing all we can to support this research and doing so as quickly as we possibly can."
Some scientists have expressed doubt that a stem cell approach can generate the results needed. In posting Sunday on The Niche stem cell blog, Sean Morrisonchairman of the Public Policy Committee at the International Society for Stem Cell Research and director of Children’s Research Institute at University of Texas Southwestern, responded to a question that asked about "potential roles for cellular therapies for COVID-19? Is there something unique they might be able to achieve that other approaches like anti-viral drugs could not?"

Morrison replied,  
"I’m afraid I’m skeptical about cellular therapies for Covid-19. Some have suggested that transplantation of immune effector cells, such as NK cells, into patients might promote a more effective immune response. I worry it will take too long for the transplanted cells to engraft and mount an effective immune response against a virus that often kills patients within days of hospitalization. 
"Others have suggested that mesenchymal stem cell (MSC) transplants might provide a benefit by attenuating the hyper-inflammation that occurs in late stage patients. While there has been some evidence that MSCs can attenuate pathological immune responses in some contexts, most clinical trials that tested this strategy failed. The other red flag is that all of the cell therapies I have seen proposed for Covid-19 have been repurposed from very different indications.
"To some extent that’s to be expected when dealing with a novel pathogen. However, it gives one pause when a cell therapy under development for cancer is suddenly touted as also having anti-viral activity. Immunologically, these are two very different problems that require very different kinds of pre-clinical testing."
The next step in CIRM's Covid-19 round is for the agency to convene a panel of scientists from out-of-state to review the applications behind closed doors and make the de facto decisions on whether to fund them. Their decisions then go to the CIRM governing board for ratification. 

At that point, summaries of the anonymous reviewers' comments on the applications become public. 

Five of the applications were from private companies and the rest from nonprofits. 

The reviewers do not publicly disclose their financial or professional conflicts of interest. Members of the governing board are barred from voting on applications involving their institutions. The research is required to be performed in California. 

Tuesday, April 07, 2020

A Grim Picture? Nuts and Bolts of California's Ballot Petition Pinch and $5.5 Billion for Its Stem Cell Research Program

Here is a not-so-hypothetical question: In these days of the coronavirus crisis, is it safe to touch a mailed-in petition to place a $5.5 billion stem cell research proposal on the November ballot?

While some may consider the question dubious, it is in, in fact, a real question for enterprises attempting to win a position on the ballot next fall. And it illustrates the difficulties facing backers of the proposed stem cell ballot measure, which is aimed at saving California's stem cell agency from financial extinction. 


The agency is running out of money and will begin to close its doors next fall unless more cash is coming in.

Lisa Renner wrote yesterday about California's ballot petition pinch for Capitol Weekly, a respected online news service that follows state governmental and political affairs. She said,

"It’s never easy to get initiatives qualified for the ballot, but this year of the COVID-19 pandemic is the worst ever....
"While organizations technically have until April 21 to turn in signatures to qualify for the November ballot, the shutdown effectively means that those that didn’t collect enough signatures by mid-March probably won’t make it. At best they can hope for possibly qualifying for November 2022."
Renner painted a vivid picture of the nuts-and-bolts of the petition business. She quoted Fred Kimball, owner of Kimball Petition Management.
"Kimball is faced with the challenge of confirming the signatures to make sure they are from unique registered voters. In a normal year, he said he has 75-100 people crammed in his office checking signatures. But this year, he has only six workers in house while the rest are looking at petitions from home.
"'I haven’t done this ever,' he said. 'Usually the petitions never leave the site of the office. There’s a lot of trust you put into the workers. It’s very difficult.'
"Some employees have quit because they don’t want to touch papers that have been handled by so many people and thus could be contaminated with the virus. To deal with that concern, Kimball has set a new rule that new signatures pages that come in his office must sit for one week before anyone touches them again. He also requires employees in house to wear masks and gloves."
Kimball's firm is working on the ballot proposals dealing with kidney dialysis and medical negligence. But his comments bear on any proposed initiative. 

In the case of the stem cell measure, it needs 623,212 valid signatures of registered voters to qualify for the ballot. Backers say they have 915,000 and need another 35,000 in order to account for disqualified signatures. They have launched an ambitious and "unprecedented" effort to circulate petitions via the Internet.

"Proponents usually seek at least 50 percent more than the legal minimum number of signatures to compensate for possible duplicate or otherwise invalid signatures," according to Wikipedia.

Capitol Weekly's Renner also reported on the stay-at-home orders facing county elections officials.

"Most have shut down all offices, requiring initiative supporters to set up appointments to drop off petitions. Much of their staff is also working at home, which sets up the new burden of getting the petitions to employees."
She continued,
"Joseph Holland, the Santa Barbara County clerk, recorder, assessor and registrar of voters, said his office hasn’t even finished certifying the March 3 election and is facing employees out sick and suddenly charged with taking care of their children after schools closed. “We are operating with a skeleton crew,” said Holland, who also serves as president of the California Association of Clerks and Elections Officials. 
"While his employees are considered essential under the shut-down order, figuring out logistics about where they sit is an issue. They can no longer sit side by side at cubicles as that would violate the 6-foot social distance rule. “It has reduced our capacity by half.” 
"For petition signatures that come in on a single page, the county is able to scan them and electronically send them to employees working at home for validation. But the county is not able to scan petitions that come in booklet form. Those must still be validated by employees at the office, Holland said."
The verification process involves random samples, which can trigger a full check of each signature, slowing the process considerably. There is a possibility that the current legal requirements could be modified, but that change would likely involve the governor and the legislature. 

The campaign for the stem cell measure has set for itself a deadline of this Saturday to finish collection of signatures. 

Friday, April 03, 2020

Final Cyberspace Dash Underway for $5.5 Billion California Stem Cell Initiative


Above is the instructional video from the stem cell initiative campaign web site. 

The campaign to save California's stem cell research program from financial extinction is making an "unprecedented," electronic sprint to gather the final signatures to qualify its $5.5 billion rescue measure for the November ballot. 

In the next eight days, the campaign says it needs 35,000 more signatures to be sure that the multi-billion-dollar ballot initiative is presented to voters next fall. 

The stem cell agency, officially known as the California Institute for Regenerative Medicine (CIRM), is running out of money. It will begin closing its doors in November without more funding.  The campaign's web site says, 
"Over 915,000 voters have already signed petitions to help qualify our initiative for the November 2020 ballot. In the last full week before public signature gathering was shut down due to the coronavirus, over 120,000 voters signed – a tremendous response. But we need at least 950,000 signatures to secure a place on the California ballot this fall. 
"Help us meet our goal by signing and returning a petition today. The campaign must gather the last 35,000 signatures through mail-in submissions by April 11th."
In response to questions from the California Stem Cell Report, campaign spokeswoman Sarah Melbostad described the online move as "unprecedented." She said,
"What’s happening right now across the world is unprecedented, which means the innovative changes we’re making to gather signatures through a mail-in option are unprecedented as well." 
The campaign's unusual Internet pitch is aimed at putting petitions in the hands of its supporters. The effort requires downloading documents, reading detailed instructions on filling them out and then returning them by regular mail. Normally, paid signature gatherers take care of all that.

The process is not simple and is likely to be daunting for some.  The campaign's web site mentions "wet signatures," the importance of printing out the 16 pages of the petition and the need to complete the "circulator declaration." A seven-minute instructional video has also been posted by the campaign (see above). 

The campaign's message stresses speed. 
"Time is of the essence; a fast response is needed to preserve our opportunity to guarantee our ballot position."
The legal minimum of valid signatures of registered voters is 623,212. The extra hundreds of thousands of signatures are needed because many are disqualified by election officials during the certification process.

The campaign's online pitch also includes a schedule of 30-minute webinars aimed at building support and answering questions. They begin tonight at 6:15 p.m. PDT and continue on April 5, 7 and 11. 

Wednesday, April 01, 2020

Backers of a $5.5 Billion California Stem Cell Measure Claim 915,000 Signatures, Ballot Qualification at Stake

The campaign to place a $5.5 billion, stem cell measure on the California ballot this fall says it has gathered more than enough signatures to bring it before voters. 

In response to questions from the California Stem Cell Report, a campaign spokeswoman said,
"In our last full week of signature gathering, we received 120,000 signatures, showing the tremendous support from California voters. With 915,000 signatures in hand and a new sign-from-home option that allows individuals to mail in their signatures, we’re confident that we will be able to gather the final signatures we need while, most importantly, keeping Californians safe." 
The proposal needs 623,212 valid signatures of registered voters to qualify. Because so many signatures are disqualified in the verification process, many more than the bare minimum are required. 

The next step is for the campaign to submit the signatures to election officials for verification, a process than can take a month or more under normal government operating conditions. 

The entire process has a deadline of June 15 to be completed.  

Campaign spokeswoman Sarah Melbostad said, "Voters can go to our website caforcures.com to sign the petition and ensure the continuation of treatments and cures that could save or improve the lives of millions."  

(Editor's note: An earlier item on this subject that was briefly up this afternoon  incorrectly said that the campaign had not responded to a question concerning the current number of signatures. That post has been deleted.)